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Results For "approval"

2479 News Found

Panacea Biotec reaches settlement with Apotex
News | July 12, 2025

Panacea Biotec reaches settlement with Apotex

Apotex will also pay US$ 2.5 million upon receipt of final USFDA approval of the ANDA that is the subject of the Collaboration Agreement for Paclitaxel Protein-Bound Particles for Injectable Suspension


Briefs: Emcure Pharmaceuticals and Gland Pharma
News | July 12, 2025

Briefs: Emcure Pharmaceuticals and Gland Pharma

Emcure Pharmaceuticals successfully completes USFDA PAI of Oncology facility


Pfizer and Astellas' Xtandi combo extends survival in early prostate cancer setting
News | July 11, 2025

Pfizer and Astellas' Xtandi combo extends survival in early prostate cancer setting

Xtandi is approved in over 80 countries, including the U.S., EU, and Japan


Novo Nordisk submits application to EMA for higher dose of Wegovy for obesity treatment
Clinical Trials | July 09, 2025

Novo Nordisk submits application to EMA for higher dose of Wegovy for obesity treatment

The submission is based on data from the STEP UP and STEP UP T2D clinical trials


OneSource Specialty Pharma appoints Jeffrey Wong as CBO
People | July 08, 2025

OneSource Specialty Pharma appoints Jeffrey Wong as CBO

He has held senior leadership positions at Syngene International, Fujifilm Diosynth Biotechnologies, Thermo Fisher Scientific, Sartorius Stedim Biotech, and other leading organizations


Veerhealth Care enters into contract manufacturing agreement
News | July 08, 2025

Veerhealth Care enters into contract manufacturing agreement

Commercial production is expected to begin soon


Imfinzi approved in the EU as first and only perioperative immunotherapy for muscle-invasive bladder cancer
Clinical Trials | July 06, 2025

Imfinzi approved in the EU as first and only perioperative immunotherapy for muscle-invasive bladder cancer

Approval based on NIAGARA Phase III trial results which showed a 32% reduction in the risk of recurrence and a 25% reduction in the risk of death for the Imfinzi regimen vs. neoadjuvant chemotherapy alone


atai and Beckley Psytech announce positive Phase 2b results for treatment-resistant depression
News | July 04, 2025

atai and Beckley Psytech announce positive Phase 2b results for treatment-resistant depression

atai and Beckley Psytech plan to meet with the U.S. Food and Drug Administration (FDA) and other regulatory agencies to finalize the Phase 3 trial design.


India exports US$ 4,961 million pharmaceutical during April–May 2025: Pharmexcil
Policy | July 02, 2025

India exports US$ 4,961 million pharmaceutical during April–May 2025: Pharmexcil

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